Amitriptyline Hydrochloride

Relieves symptoms of depression. ANDA 215376, held by Rubicon Research. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 215376 (Amitriptyline Hydrochloride), held by Rubicon Research, was first approved by FDA on May 1, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: May 1, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 1, 2023	Original application	Approved	None posted

Products

6 strengths and forms


Amitriptyline Hydrochloride10MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride25MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride50MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride75MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride100MG · tablet;oral	Amitriptyline Hydrochloride	Rx
Amitriptyline Hydrochloride150MG · tablet;oral	Amitriptyline Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 3Labeling · Standard review	Approved	None posted
May 1, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 215376
Drugs@FDA: Overview at FDA
Company: Rubicon Research

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters